Class: NSAID, Analgesic

Manufacturer: Umedica Laboratories Pvt. Ltd., Gujarat, India

Dosage Form: Tablet

Similar Brands:

Uses:

Rilif plus is indicated for the treatment of acute painful inflammatory conditions with or without associated fever.

Dosage:

Rilif plus tablets are supplied for oral administration in adults. The maximum recommended dose of rilif plus is two tablets daily, taken as one tablet in the morning and one in the evening.

Side Effects:

Undesirable effects associated with NSAIDs in general:

Gastrointestinal – the commonly observed adverse events area gastrointestinal in natured. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, malaemia, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported following administration. Less frequently, gastritis has been observed.

Vascular and cardiac disorders – oedema, hypertension and cardiac failure have been reported in association with NSAIDs treatment. Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke)

Other rare or very rare class of effects reported with NSAIDs in general are:

Blood and the lymphatic system disorders – aplastic anaemia.

Psychiatric disorders – hallucinations, confusion state.

Nervous system disorders – optic neuritis, somnolence.

Ear and labyrinth disorders – tinnitus.

Respiratory, thoracic and mediastinal disorders – aggravated asthma.

Skin and subcutaneous tissue disorder – toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, photosensitivity reaction.

Renal and urinary disorders – interstitial nephritis.

General disorders and administration site conditions – malaise.

Paracetamol:

Hematologic: hemolytic anemia, neutropenia, leucopenia, pancytopenia, thrombocytopenia.

Hypersensitivity: skin eruptions, urticaria, erythema, fever.

Miscellaneous: hypoglycemic coma, jaundice.

Warnings & Precautions:

• Close medical surveillance is imperative in patients with symptoms indicative of gastrointestinal disorders, with a history suggestive of gastrointestinal ulceration, with ulcerative colitis or with Crohn’s disease, bleeding diathesis or haeatological abnormalities.
• Gastrointestinal bleeding or ulcerative perforation, haematemesis and melaena have in general more serious consequences in the elderly. They can occur at any time during treatment, with or without warning symptoms or previous history. In the rare instances, where gastrointestinal bleeding or ulceration occurs in patients receiving aceclofenac, the drug should be withdrawn. Close medical surveillance is also imperative in patients suffering from severe impairment of hepatic function
• Aceclofenac should be given with caution to elderly patients with renal, hepatic or cardiovascular impairment and to those receiving other medication. The lowest effective dose should be used and renal function monitored regularly.
• As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to the drug.
• The importance of prostaglandins in maintaining renal blood flow should be taken into account in patients with impaired cardiac or renal function, those being treated with diuretics or recovering from major surgery. Effects on renal function are usually reversible on withdrawal of aceclofenac.
• Caution should also be exercised in patients with history of coagulation defects and history of liver dysfunction.
• Renal and hepatic function and blood counts should be monitored during long term treatment. Persistently elevated hepatic enzyme levels necessitate withdrawal of aceclofenac.
• Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive paracetamol use, although reports of this event are rare. Reports almost invariably involve cases of severe chronic alcoholics and the dosages of paracetamol most often exceed recommended doses and often involce substantial overdose. Caution should be taken in patients who regularly consume large amounts of alcohol. Such patients should not exceed the maximum recommended doses of rilif plus.

Pregnancy & Lactation:

The drug is not recommended in pregnancy.

Lactation

The drug is recommended in breast feeding women.

Drug Interactions:

Drug interactions associated with rilif plus are similar to those observed with other NSAIDs. Aceclofenac may increase plasma concentration of lithium, digoxin and methotrexate, increase the activity of anticonagulants, inhibit the activity of diuretics, enhance cyclosporine nephrotoxicity and precipitate convulsions when co-administered with quinolone antibiotics. When concomitant administration with potassium sparing diuretics is employed, serum potassium should be monitored.

Furthermore, hypo or hyperglycemia may result from the concomitant administration of aceclofenac and antidiabetic drugs, although this is rare. The co-administration of aceclofenac with other NSAIDs or corticosteroids may result in increased frequency of side effects.

Caution should be exercised if NSAIDs and methotrexate are administered within 2-4 hours of each other, since NSAIDs may increase methotrexate plasma levels, resulting in increased toxicity.

Potential hepatotoxicity of paracetamol may be increased by large doses or long-term administration of barbiturates, carbamazepine, hydantoins, isoniazid, rifampicin and sulfinpyrazone.

Contraindications:

• Hypersensitivity to aceclofenac or paracetamol or any component of the tablet.
• In patients in whom substances with a similar action (e.g. aspirin, or other NSAIDs), precipitate attacks of asthma, bronchospasm, acute rhinitis or urticaria or patients are hypersensitive to these drugs.
• Severe heart failure or severely impaired hepatic or renal organ function and during the last three months of pregnancy.

Price: Ksh 750

Notes:

Pack Size: 30s